Intuitive Surgical, Inc. has recalled 219 units of the da Vinci X, Xi, and da Vinci 5 Surgical Systems due to a software implementation error. This error allowed robotic instrument arms that failed a critical diagnostic test to remain in clinical use when they should have been flagged for maintenance. The failure to detect these faulty arms can lead to the 'ball screw' component bending or breaking during surgery. Intuitive Surgical is notifying affected hospitals and surgical centers by letter to address this software defect.
A bent or misaligned ball screw in the surgical arm can eventually fracture, causing the robotic arm to lose its ability to move or track the surgeon's commands precisely during a procedure. This failure could result in surgical delays, unintended tissue damage, or the need to convert to a more invasive open surgery.
Affected part is the Universal Surgical Manipulator (USM) sub-component, part number 380647-xx.
Specifically da Vinci X (O.U.S.) models.
Specifically da Vinci 5 (U.S.) models.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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